PORT-X IV
K-Number: K172810 · 2018-03-07
ApplicantGenoray Co., Ltd.
Decision Date2018-03-07
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
PORT-X IV is a medical device manufactured by Genoray Co., Ltd.. It received FDA 510(k) clearance on 2018-03-07 under approval number K172810. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PORT-X IV?
PORT-X IV is a medical device that received FDA 510(k) clearance on 2018-03-07. It is manufactured by Genoray Co., Ltd.. The 510(k) number is K172810.
When was PORT-X IV approved by the FDA?
PORT-X IV received FDA 510(k) clearance on 2018-03-07, under approval number K172810.
What company makes PORT-X IV?
PORT-X IV is manufactured by Genoray Co., Ltd..
What is the FDA product code for PORT-X IV?
The FDA product code for PORT-X IV is EHD.
Other Devices by Genoray Co., Ltd.
Related Devices (Code: EHD)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.